Z-3016-2020Class II

Kit, Pre Op Drah -

Name: Z-3016-2020 Kit, Pre Op Drah -
Creator: Cardinal Health 200, LLC
Published: 2020-07-30
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2020-07-30 / Terminated / root cause: manufacturing process

FDA source

Cardinal Health 200, LLC began a recall of KIT, PRE OP DRAH - Product Usage: Preoperative kit used to decolonize intranasal S. aureus on 2020-07-30. FDA classified it as Class II and gives the reason as "Only providing one nasal swab in our pre-operative kit instead of the 4 required for proper treatment". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3016-2020
Classification: Class II
Status: Terminated
Initiated: 2020-07-30
Posted: 2020-09-25
Terminated: 2021-04-28
Recalling firm: Medtronic, Inc.
Product: KIT, PRE OP DRAH - Product Usage: Preoperative kit used to decolonize intranasal S. aureus.
Product code: LRP Tray, Surgical
Reason for recall: Only providing one nasal swab in our pre-operative kit instead of the 4 required for proper treatment.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: On July 30th the firm send its consignee a letter notifying them of the field action. Component Part Number: X12048 (SWABSTICK, PVP-I,10%, NASAL DECOLONIZATION, PROFEND,NS) is supplied to Cardinal Health, Presource in a package of 4 nasal swabs. Per the suppliers Instructions for Use, X12048 is a kit that needs to be administered in a 4-swab treatment with two swabs used per nasal passage. Presource is only providing one nasal swab in our pre-operative kit instead of the 4 required for proper treatment. The Presource kit was set up requiring 1 each of the swab component, but confusion in the component set-up caused 1 swab to be kitted instead of 1 package of 4 swabs.
Quantity in commerce: 9,150 kits
Distribution: US Nationwide distribution including the state of North Carolina.
Product codes and lots: Model: ORPDH5994A Lot numbers: 558357, 561502,566549, 571467, 574058. Expiration dates: Varies by kit components.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3016-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3016-2020	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-09-25

Product code LRP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)